Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Topical Solution

Brand(s)
Artiss, Tisseel
Category(s)
other, prescription
SPL Type(s)
Human Prescription, Plasma Derivative
Master SPL
Baxter Healthcare Corporation (2013-09-03)
Oldest Current Product
1998-05-01
License(s)
BLA
RxNORM
TOPICAL SOLUTION\CALCIUM CHLORIDE:FIBRINOGEN:FIBRINOLYSIS INHIBITOR:THROMBIN

product(s) by strength(s)

calcium chloride 0.04 meq/ml / fibrinogen 106 mg/ml / fibrinolysis inhibitor 3750 unt/ml / thrombin (human) 6.5 unt/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1009444351ArtissBLABaxter Healthcare Corporation2008-03-19, 2011-01-1112526613f76667-ec2f-4fa7-a9e8-12502d8224db, 25fabd0d-0adc-465c-8bab-18ff45ba6186, 38a6412e-9557-45ad-a917-da15109657ec, b753fc2e-5b61-4916-ba3f-5a7f03172156, bd90793f-a6db-4cc3-8336-20b22d37a5ec, f2ca0bf3-f8ef-4d1a-a32c-623189ec2e5e

calcium chloride 0.04 meq/ml / fibrinogen 106 mg/ml / fibrinolysis inhibitor 3750 unt/ml / thrombin (human) 625 unt/ml topical solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedapplicationspl
1009444210TisseelBLABaxter Healthcare Corporation1998-05-0110398060e8272e-2a7d-42a5-af4b-3dbf727dd68f, 7d7abda1-9b76-43b2-8f74-0e376d9fe264
2009444301TisseelBLABaxter Healthcare Corporation1998-05-0110398060e8272e-2a7d-42a5-af4b-3dbf727dd68f, 7d7abda1-9b76-43b2-8f74-0e376d9fe264
3009444302TisseelBLABaxter Healthcare Corporation1998-05-0110398060e8272e-2a7d-42a5-af4b-3dbf727dd68f, 7d7abda1-9b76-43b2-8f74-0e376d9fe264

application(s)

#idtitleapprovedtradenamesfda division
1103980Fibrin Sealant (Tisseel) Application1998-05-01TISSEELCBER
2125266Fibrin Sealant (Human) Application2008-03-19ARTISSCBER

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1106365cb-71aa-4c20-af32-5bbfe8cbf191 (view SPL)These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 1998otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2010-10-081009444201
213f76667-ec2f-4fa7-a9e8-12502d8224db (view SPL)These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS ARTISS [Fibrin Sealant (Human)]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 2008prescriptionHuman PrescriptionBaxter Healthcare CorporationMANUFACTURE2010-12-2312009444351, 009448503Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Prefilled Applicator
325fabd0d-0adc-465c-8bab-18ff45ba6186 (view SPL)These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS ARTISS [Fibrin Sealant (Human)]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 2008prescriptionHuman PrescriptionBaxter Healthcare CorporationMANUFACTURE2010-12-2311009444351, 009448503Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Prefilled Applicator
431bc99f4-c504-4e6a-8bb6-fe8f7a5c2424 (view SPL)These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 1998otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2010-10-081009444201, 009448402
538a6412e-9557-45ad-a917-da15109657ec (view SPL)These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS ARTISS [Fibrin Sealant (Human)]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationincludes DUPLOJECTInitial U.S. Approval: 2008otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-08-295009444351
660e8272e-2a7d-42a5-af4b-3dbf727dd68f (view SPL)These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 1998otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2013-09-032009444210, 009444301, 009444302, 009444211, 009444212, 009444303, 009448402Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Prefilled Applicator
77d7abda1-9b76-43b2-8f74-0e376d9fe264 (view SPL)These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 1998otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2013-09-031009444210, 009444301, 009444302, 009444211, 009444212, 009444303, 009448402Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Prefilled Applicator
8b753fc2e-5b61-4916-ba3f-5a7f03172156 (view SPL)These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS ARTISS [Fibrin Sealant (Human)]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationincludes DUPLOJECTInitial U.S. Approval: 2008otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-08-294009444351
9bd90793f-a6db-4cc3-8336-20b22d37a5ec (view SPL)These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS ARTISS [Fibrin Sealant (Human)]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 2008otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-08-2912009444351, 009448503Calcium Chloride / Fibrinogen / fibrinolysis inhibitor / Thrombin Prefilled Applicator
10c21e996f-e555-4b27-9da7-cf0600953646 (view SPL)These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 1998otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2010-10-081009444201, 009448402
11dc1d15c7-757f-470f-83c2-14b3d6512483 (view SPL)These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 1998otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2010-10-081009444201
12e1aca067-0c96-4025-88bc-bd2345a46a30 (view SPL)These highlights do not include all the information needed to use TISSEEL safely and effectively. See full prescribing information for TISSEEL. TISSEEL [Fibrin Sealant]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationInitial U.S. Approval: 1998otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2010-10-081009444201
13f2ca0bf3-f8ef-4d1a-a32c-623189ec2e5e (view SPL)These highlights do not include all the information needed to use ARTISS safely and effectively. See full prescribing information for ARTISS ARTISS [Fibrin Sealant (Human)]For Topical Use OnlyFrozen solution and lyophilized powder for solution for topical applicationincludes DUPLOJECTInitial U.S. Approval: 2008otherPlasma DerivativeBaxter Healthcare CorporationMANUFACTURE2011-08-295009444351

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII